Jane, S.W., Chen, S.L., Wilkie, D.J., Lin, Y.C., Foreman, S.W., Beaton, R.D., . . . Liao, M.N. (2011). Effects of massage on pain, mood status, relaxation, and sleep in Taiwanese patients with metastatic bone pain: A randomized clinical trial. Pain, 152, 2432–2442.
To compare the efficacy of massage therapy to a social attention condition in Taiwanese patients with cancer with bone metastases
The study was a randomized, controlled clinical trial.
This trial documented therapeutic effects of massage on improving pain intensity, mood status, and muscle relaxation in patients with metastatic bone pain. The study has clinical implications supporting massage therapy and other medical modalities for optimal improvement in patients with cancer with bone metastases.
Massage therapy may play an important role in cancer bone pain, sleep, and, mood.
Jandhyala, R., & Fullarton, J. (2012). Various formulations of oral transmucosal fentanyl for breakthrough cancer pain: An indirect mixed treatment comparison meta-analysis. BMJ Supportive and Palliative Care, 2, 156–162.
PHASE OF CARE: Multiple phases of care (not reported)
APPLICATIONS: Palliative care
No head to head trials between products existed. FBT produced a greater improvement in PID in the first 60 minutes after dosing (66% more probable than ODT and 68% more than OTFC). ODT and OTFC showed similar benefits, and ODT had a slightly higher benefit with a 53% probability of pain relief at 60 minutes. The two agents compared with morphine sulfate immediate-release, FBT and ODT, were compared, and benefits were significant within 15 minutes after dosing.
FBT may be advantageous as a fentanyl product, as it showed an advantage over ODT and OTFC.
Two of the trials compared FBT to a placebo, so more paitents received FBT. Therefore, cell sizes were not similar, resulting in an unequal comparison. Seven transmucosal immediate-release fentanyl (TIRF) studies existed. Only three were used in the comparison. Limited databases were searched.
Some TIRF products may have better efficacy compared to others. This analysis showed that FBT had an advantage. All products were shown to be superior to morphine in achieving pain relief one hour after dosing. Additional head to head comparison studies are needed.
Jandhyala, R., Fullarton, J.R., & Bennett, M.I. (2013). Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: A meta-analysis of comparative trials. Journal of Pain and Symptom Management, 46, 573–580.
STUDY PURPOSE: To evaluate the efficacy of oral fentanyl combinations for breakthrough cancer-related pain
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: PubMed
KEYWORDS: breakthrough cancer pain; incident pain; pain flare; morphine; fentanyl
INCLUSION CRITERIA: RCT
EXCLUSION CRITERIA: Not specified
TOTAL REFERENCES RETRIEVED: Not stated
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not stated
APPLICATIONS: Palliative care
The probability of superior relief of breakthrough pain by differences in pain intensity scores at 15- and 60-minute intervals was calculated for immediate-release morphine and fentanyl preparations, versus placebo and versus each other. There was a 61% probability that morphine would produce a better outcome than placebo. Corresponding results versus placebo for fentanyl buccal tablet (FBT) was 97%, for orally disintegrating tablet (ODT) was 72%, and for transmucosal oral fentanyl (OTF) tablet was 81%. The probability of superiority of fentanyl over morphine during the first 60 minutes was 68% for FBT, 57% for ODT, and 66% for OTF. Pain intensity differences were larger for fentanyl preparations than for morphine when compared to placebo.
Findings suggest that oral fentanyl preparations may provide better relief of breakthrough pain during the first 60 minutes than immediate-release oral morphine.
Findings suggest that oral fentanyl preparations may be more effective for management of breakthrough pain than oral immediate-release morphine. It should be noted however, that the duration of effect with morphine could be longer because of differences in half-life. Onset, intensity, and duration of relief of breakthrough pain with various approaches need to be evaluated to determine the best approach for individual patients.
Jain, S., Pavlik, D., Distefan, J., Bruyere, R. L., Acer, J., Garcia, R., . . . Mills, P. J. (2012). Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial. Cancer, 118, 777–787.
To examine, within a blinded, randomized, controlled trial design, whether biofield therapy (hands-on healing) would significantly reduce fatigue in survivors with persistent cancer-related fatigue compared to mock healing and a wait-list control group.
Energy chelation (hands-on-healing with standard hand positions focusing for five to seven minutes over each body part, i.e., feet, hips, knees, bladder, stomach, hands, elbows, shoulders, heart, throat, head, and heart) for one hour, two times each week for four weeks in the intervention group; mock biofield therapy for one hour, two times each week for four weeks; and a wait-list with no specific intervention. All participants submitted saliva samples at four time points. Timing of self-reported measures of quality of life (QOL) and depression were not reported.
The study used a blinded, randomized, controlled design.
Nonspecific factors are important in responses to biofield interventions for fatigue. Belief predicts QOL responses but not fatigue or cortisol variability. Biofield therapies increase cortisol variability independent of belief and other nonspecific factors. A need exists to further examine the effects of specific processes of biofield healing on outcomes for cancer populations.
Use of a hands-on healing intervention takes time and a skill set not traditionally taught in undergraduate or graduate nursing programs. Few clinical nurses have the time or skills to practice hands-on healing as described in the study. The intervention is noninvasive and a potentially effective independent nursing intervention with a minimal side effect profile.
Jain, S., & Mills, P. J. (2010). Biofield therapies: helpful or full of hype? A best evidence synthesis. International Journal of Behavioral Medicine, 17, 1–16.
To determine whether biofield therapies affect positive health outcomes and reduce disease symptoms.
Databases searched were PubMed, CINAHL, PyscINFO, and Allied and Complementary Medicine (AMED).
Search keywords were spiritual healing, subtle energy, energy healing, biofield healing, external qi therapy, emitted chi, emitted qi, qi therapy, Johrei, pranic healing, polarity therapy, Reiki, therapeutic touch, and healing touch. Investigators also manually searched the reference sections of studies and review papers.
Studies were included if they
Studies were excluded if they related to distant healing or intercessory prayer; integrated modalities that were not biofield-based modalities with biofield-based modalities in such a way that the interventions could not be separated; were animal, plant, and/or in vitro studies; were clinical studies with group assignment but without randomization; were purely descriptive studies; or were unpublished dissertations.
Patients were undergoing the active treatment phase of care.
The authors presented results according to type of patient and levels of evidence.
Proximally practiced biofield therapies are promising complementary interventions as means of reducing pain intensity in multiple populations, reducing anxiety in hospitalized populations, and reducing agitated behaviors in patients with dementia. The long-term effects of the therapies on fatigue and autonomic nervous system activity are unclear.
Future research should compare biofield therapies with empirically supported treatments for specific conditions.
Jaing, T.H., Tsay, P.K., Hung, I.J., Yang, C.P., & Hu, W.Y. (2004). Single-dose oral granisetron versus multidose intravenous ondansetron for moderately emetogenic cyclophosphamide-based chemotherapy in pediatric outpatients with acute lymphoblastic leukemia. Pediatric Hematology and Oncology, 21, 227–235.
To compare the efficacy of multidose ondansetron with single-dose granisetron in complete emesis control and time spent in an ambulatory care setting in children with acute lymphoblastic leukemia (ALL) receiving moderately emetogenic cyclophosphamide-based chemotherapy
Eligible patients entered a four-week run-in period during which they were given antiemetic agents according to the randomization scheme before their scheduled IV cyclophosphamide chemotherapy. Regimens were either single-dose granisetron (0.5 mg for patients weighing 25–50 kg or 1 mg for patients over 50 kg) administered orally one hour before chemotherapy or three doses of ondansetron (0.15 mg/kg administered IV one hour before chemotherapy and again four hours after the first dose with an additional oral dose eight hours after the first dose). Parents were asked to keep a log of their child’s emetic episodes during the first 24 hours following chemotherapy. Antiemetic efficacy was assessed by the number of vomiting episodes, the need for rescue medication, and the extent of nausea and appetite loss.
Single-institution, randomized, open-label, two-period crossover investigation
In the granisetron arm, 20 out of 33 patients (60.6%) experienced complete efficacy compared to 15 out of 33 patients (45.5%) in the ondansetron arm, this was not statistically significant (p = 0.227). In both treatment groups, that males were less likely to respond to antiemetic treatment than females. In the granisetron group, 100% (12 out of 12) of females versus 76.2% (16 out of 21) of males experienced complete efficacy. In the ondansetron group, 100% (12 out of 12) of females versus 81% (17 out of 21) of males experienced complete efficacy. These differences did not meet a statistical significance (p = 0.271). The cost analysis demonstrated that granisetron costs about $0.20/kg (20 mcg/kg per patient), and ondansetron costs $20.09 per 8 mg vial or $6.18 per 4 mg tablet. This equates to about $0.99/kg (0.15 mg/kg per patient). The drug cost differential between the two modalities is $0.79/kg, favoring granisetron therapy on the basis of cost.
A single prophylactic oral dose of granisetron (10–20 mcg/kg) given prior to moderately emetogenic chemotherapy was at least as safe and effective as a triple dose of ondansetron given under similar circumstances. It also was more cost effective.
Based on this study, a single dose of oral granisetron (10–20 mcg/kg) is as safe and effective as a triple dose of ondansetron for moderately emetogenic chemotherapy in children with ALL in the acute phase of chemotherapy-induced nausea and vomiting only. There seems to be a gender difference in antiemetic efficacy.
Jahr, S., Schoppe, B., & Reisshauer, A. (2008). Effect of treatment with low-intensity and extremely low-frequency electrostatic fields (Deep Oscillation) on breast tissue and pain in patients with secondary breast lymphoedema. Journal of Rehabilitation Medicine: Official Journal of the UEMS European Board of Physical and Rehabilitation Medicine, 40(8), 645–650.
To evaluate the symptoms and functional limitations of patients with secondary breast lymphedema following surgical treatment and to assess the additional therapeutic benefit of Deep Oscillation when combined with manual lymphatic drainage
Patients were randomized to the treatment group or the control group. The treatment group received 12 sessions of manual lymphatic drainage supplemented by Deep Oscillation, and the control group received manual lymphatic drainage alone.
The study took place at a single site in Berlin, Germany.
The study used a randomized controlled trial design.
Patients had high pain and swelling scores at baseline. Shoulder mobility was impaired in all patients; restriction of cervical spine mobility was common at baseline and declined further in the control group. Deep Oscillation resulted in significant pain reduction in the treatment group. The subjective reported reduction of swelling was confirmed objectively by 3D measurement only in the treatment group.
Additional Deep Oscillation supplementary to manual lymphatic drainage can enhance pain alleviation and swelling reduction.
More attention should be paid to patients with breast lymphedema. Treatment with low-intensity and extremely low-frequency electrostatic fields could be a useful supplementary therapy in the management of patients with breast lymphedema. However, more studies with larger sample sizes are needed to duplicate the findings from this study.
Jahn, P., Renz, P., Stukenkemper, J., Book, K., Kuss, O., Jordan, K., … Landenberger, M. (2009). Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: A cluster-randomized multicenter trial. Supportive Care in Cancer, 17, 1543–1552.
To evaluate a multi-modular self-care program, Self-Care Improvement through Oncology Nursing (SCION), consisting of emesis treatment, nutritional support, counseling, and relaxation interventions to reduce anorexia, nausea, and emesis (ANE)
Patients were randomized to receive either standard care (control) or the SCION program, which included four modular, algorithm-based protocols. In the intervention group, all patients received Module 1, \"Information leaflet,\" and Module 2, \"Structured consultation,\" at various times during treatment. Module 3 “Nutrition counseling” and Module 4 “Relaxation” were given if a patient developed significant nausea, emesis, or weight loss. Patients in the control group received set emesis prophylaxis. Assessments were made on days 1–5 of two chemotherapy cycles and day 8 of the second cycle.
The study was conducted in inpatient and outpatient settings at two German university hospitals.
All patients were in active treatment.
This was a randomized, controlled study.
The initial hypothesis, that a structured intervention for patients receiving chemotherapy with moderate or high emetogenic potential would significantly decrease ANE intensity, was not supported. The effectiveness of the nursing intervention to reduce chemotherapy-induced ANE and increase QOL could not be supported. Rather, the intervention was reported to have a negative effect on QOL.
The SCION program had no effect in reducing distressing ANE.
Jahn, P., Kuss, O., Schmidt, H., Bauer, A., Kitzmantel, M., Jordan, K., . . . Landenberger, M. (2014). Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: A cluster-randomized multicenter trial. Pain, 155, 746–754.
To evaluate Self Care Improvement through Oncology Nursing (SCION-PAIN), a nursing-administered program to reduce patients’ barriers and improve pain management and pain-related discharge management
The intervention was a nurse-led counseling program to improve pain management and pain-related discharge management by reducing patient-related cognitive barriers. In the intervention group, the SCION-PAIN program was administered by specially trained ward nurses in cooperation with a study nurse. Initial education was standardized, and follow-up was tailored to individual needs. Three initial sessions were provided during hospital stay, and a follow-up telephone counseling session was done two to three days after discharge. Study measures were obtained at baseline, at discharge, and on days 7, 14, and 28 after discharge.
Cluster-randomized trial
Compared to usual care, the SCION-PAIN program reduced cognitive barriers in cancer pain management more effectively (p < 0.02), and patients who participated in this program showed a significant increase in perceived knowledge of cancer pain. There was no difference between the groups in average or worst pain intensity. Patients in the intervention group adhered better to pain medications (p = 0.02).
The results of this study demonstrated the effectiveness of the SCION-PAIN program as a brief, easily administered, nurse-led intervention to improve the self-management of pain in patients with cancer. Patient education could help to empower patients to actively participate in their pain treatment and develop self-management skills, improving adherence through care transitions. Participants in the program demonstrated a lower intensity of pain.
The results of this study emphasized the integral role of nurses as part of the supportive or palliative care team. This study also confirmed that the inpatient period provides a very valuable and suitable timeframe to improve patients’ self-management and communication skills to prepare them for care transitions.
Jahangard-Rafsanjani, Z., Gholami, K., Hadjibabaie, M., Shamshiri, A.R., Alimoghadam, K., Sarayani, A., . . . Ghavamzadeh, A. (2013). The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: A randomized clinical trial. Bone Marrow Transplantation, 48, 832–836.
To evaluate the efficacy of selenium intake for prevention of oral mucositis (OM) in patients with hematologic malignancies who are candidates for allogeneic hematopoietic stem cell transplantation (HSCT) after receiving high-dose chemotherapy (HDC)
Patients randomly were assigned to the selenium or control group in a blocked, randomization schedule. They were given either a selenium tablet (200 mcg) or placebo tablet twice daily, from the starting day of HDC to 14 days after transplantation. Chemotherapy was the same for all patients. All patients received a similar regimen for prevention of mucositis, including nystatin, sucralfate, and mouthwashes with chlorhexidine, plus 10 cc diluted povidone-iodine every three hours. Narcotic analgesics rarely were used to alleviate OM.
The cumulative incidence of OM (WHO scale grades of 1–4) in the selenium group and control group was not significantly different. The incidence of severe OM (grades 3 and 4) was significantly lower in the selenium group (10.8% versus 35.1%, P = 0.013). Two patients in the control group experienced WHO OM grade 4, and none of the patients in the selenium group experienced grade 4. Mean duration of OM was not different between the two groups. Mean duration of OM from the beginning of grade 2, moving up to grade 4, and then returning to grade 2 was significantly lower in the selenium group. No difference was seen in the start day of OM between the two groups.
Selenium supplementation during HDC may prevent severe OM in patients undergoing allogeneic HSCT. Further testing is needed before selenium can be recommended. Further testing is needed to establish optimal dose, time to initiate, and duration of treatment with selenium.
Nurses need to be informed about possible effective methods for reducing and eliminating OM to guide their patients.